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Novara Registry of Platinum-Chromium Platform Stents

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Azienda Ospedaliero Universitaria Maggiore della Carita

关键词

抽象

Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms . This analysis aims to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population using quantitative angiographic analysis (QCA).

描述

Aims: Recent reports have described cases of novel thin-strut coronary stent longitudinal deformation during or after deployment and a biomechanical analysis have suggested increased susceptibility for such a complication for the platinum chromium (PtCr) coronary stent platforms .

The aim of this analysis is to assess the incidence of longitudinal stent deformation for PtCr stents in a large single centre all-comers population .

Methods: Quantitative angiographic analysis (QCA) of PtCr stents deployed in consecutive all-comers patients treated in our Laboratory from January 2011 to August 2012 will be performed by an independent core laboratory. In particular QCA : nominal stent lenght ratio will be calculated for every PtCr stent.

Clinical follow up with data about overall and cardiac mortality, myocardial infarction and target vessel revascularization will also be performed.

日期

最后验证: 02/28/2015
首次提交: 12/15/2012
提交的预估入学人数: 12/29/2012
首次发布: 01/02/2013
上次提交的更新: 03/24/2015
最近更新发布: 03/25/2015
实际学习开始日期: 12/31/2011
预计主要完成日期: 09/30/2015
预计完成日期: 11/30/2015

状况或疾病

Fracture of Stent of Coronary Artery
External Causes of Morbidity and Mortality
Myocardial Infarction
Coronary Vessel Disorders

干预/治疗

Device: PtCr stent PCI treated patients

-

手臂组

干预/治疗
PtCr stent PCI treated patients
patients treated with PCI in whichat least 1 PtCr stent was used
Device: PtCr stent PCI treated patients
PCI with deployment of at least 1 PtCr stent

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
取样方式Probability Sample
接受健康志愿者
标准

Inclusion Criteria:

- PCI with at least 1 platinum-chromium platform-based stent

- presence of at least 2 ortogonal angiographic projections of the deployed stent to allow proper quantitative coronary angiography

Exclusion Criteria:

- age <18 >90

结果

主要结果指标

1. QCA : nominal stent lenght ratio [1 day]

QCA measured lenght of the deployed stent divided for the nominal stent lenght, a surrogate marker for stent deformation

次要成果指标

1. cardiovascular mortality [1 year]

death from cardiac or vascular causes

2. myocardial infarction [1 year]

recurring myocardial infarction (MI), according to the novel 3rd definition of MI

3. target vessel failure [1 year]

any clinically-driver revascularization of the treated coronary vessel

4. Macroscopical stent deformation [1 day]

severe stent deformation after deployment or other interventional manouvres (postdilation, IVUS, etc.)

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